The US Food and Drug Administration has granted De Novo approval to Happiest Baby’s SNOO Smart Sleeper, a baby bed designed to keep sleeping babies positioned on the back—a position known to lower the risk of sudden infant death syndrome (SIDS).

Every year, 3,500 American babies die in their sleep from suffocation and unexplained causes, including SIDS. These deaths are collectively referred to as SUID (sudden unexpected infant death) and constitute the leading cause of death of healthy, full-term infants during the first year of life (90% of SUID cases occur in the first six months).

In the 1990s, doctors discovered that sleeping on the back dramatically reduced the incidence of SUID. Today, it is one of the key safe sleep recommendations of the American Academy of Pediatrics. The National Institutes of Health encourages back sleeping as “the single most effective action that parents and caregivers can take to lower a baby’s risk of SIDS.” And, the Centers for Disease Control and Prevention advises that “babies who sleep on their backs are much less likely to die of SIDS than babies who sleep on their sides or stomachs.”

Despite this universal recommendation, almost two-thirds of SUID deaths still occur when babies roll to, or are placed on, the side or stomach. 

The SNOO Smart Sleeper bassinet plus the SNOO Sleep Sack are jointly intended to facilitate a supine position during sleep. The SNOO Sack swaddles babies and attaches to the bed, keeping them securely on the back throughout sleep. SNOO is for use by babies under 6 months of age or until they have demonstrated they can consistently roll from stomach to back during sleep. 

In a study of 1,012 infants, SNOO was found to reduce unsafe stomach sleeping by 91.5%. However, SNOO has not directly demonstrated a reduction in the incidence of SIDS/SUID.

“As a pediatrician for over 40 years, I’ve witnessed far too many times the unbearable pain of parents who placed their baby in bed at night, only to find them lifeless in the morning,” says Harvey Karp, MD, co-founder and CEO of Happiest Baby Inc, in a press release. “Stomach sleeping leads to the tragic death of thousands of healthy infants every year. Yet, we routinely put babies in bed totally unsecured for 12 to 14 hours every day. Just as infant seats dramatically improve car safety, we hope to dramatically improve sleep safety by keeping babies on the back and reducing risky rolling.”

Photo caption: SNOO is granted FDA De Novo approval for keeping sleeping babies safely positioned on the back.

Photo credit: PRNewsfoto/Happiest Baby, Inc.